Novel “Umbrella Trial” Approach Involves Multiple Sponsors and Collaborators to Help Accelerate Precision Therapies Based on Patients’ Genomic Profiles
RALEIGH, N.C. – November 7, 2016 – INC Research Holdings, Inc. (Nasdaq:INCR), a leading, global Phase I to IV contract research organization, today announced its involvement in The Leukemia & Lymphoma Society’s (LLS) recently launched precision medicine Master Trial to treat acute myeloid leukemia (AML). The Beat AML Master Trial is breaking ground in a number of areas, including the first time a non-profit organization is working with multiple biotechnology and pharmaceutical sponsors and other key collaborators to professionally operationalize a study. The trial will provide principal investigators and their patients consolidated access to test novel therapies matched to specific molecular aberrations in AML.
The LLS designed the Beat AML Master Trial as an umbrella trial, which differs from traditional trials in that newly diagnosed AML patients will enter this study based on screening for specific molecular mutations known to be drivers of their disease, and will be matched to a specific targeted therapy for that aberration. The LLS expects the scope of the multi-year trial to include 15 to 20 clinical research sites, up to 10 different treatment arms and 500 patients.
“The Beat AML Master Trial is a significant milestone for LLS, specifically its commitment to helping AML patients, for whom there has not been an advance in standard treatment in more than 40 years,” said Louis J. DeGennaro, PhD, LLS President and CEO. “LLS is uniquely able to convene this collaboration, which marks the first time that the organization has functioned as the sponsor of a clinical trial. Working with INC Research will allow us to tap into the Company’s long-established relationships with physicians and medical centers to ensure timely delivery of data, a crucial element of this precision medicine approach.”
INC Research was selected to manage the Beat AML Master Trial based on extensive experience with AML clinical research and the Company’s robust reputation in the field of hematologic malignancies. In the past five years, the Company’s Oncology business unit has conducted 40 leukemia studies at more than 1,000 clinical research sites worldwide involving nearly 5,500 patients. INC Research will provide a full range of CRO services for the Master Trial ranging from study start-up to project management and clinical operations to biostatistics and medical writing.
“Even though there has been intense clinical trial activity, and research has led to a much deeper understanding of the molecular biology of AML, treatment standards have not been able to advance in the past several years; this remains a disease with poor prognosis,” said Nicholas Kenny, PhD, Executive Vice President and General Manager for Oncology at INC Research. “INC’s Oncology team is therefore thrilled to be engaged with LLS in this groundbreaking study. The collaboration LLS has created among biopharmaceutical companies, leading AML clinical researchers from the U.S., the FDA and multiple support groups is impressive. We anticipate this will be a landmark trial for AML patients – particularly because it moves multiple targeted therapies into an up-front/newly diagnosed AML setting while concurrently offering physicians and patients a truly targeted approach to the disease.” Dr. Kenny concluded, “We applaud LLS for taking such a progressive approach to find solutions for this lethal blood cancer. Our shared hope is that AML, like CLL and CML, will yield clinical progress in the face of our advanced knowledge of the disease and the associated targeted therapies.”
For more information on the Beat AML Master Trial and its collaborators, visit https://www.lls.org/.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care. Founded in 1949 and headquartered in Rye Brook, N.Y., LLS has chapters throughout the United States and Canada. To learn more, visit LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. EST.
About INC Research
INC Research (Nasdaq:INCR) is a leading global contract research organization (CRO) providing the full range of Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industries. Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market. The Company was named “Best Contract Research Organization” in December 2015 by an independent panel for Scrip Intelligence, and ranked “Top CRO to Work With” among large global CROs in the 2015 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, N.C., with operations across six continents and experience spanning more than 110 countries.
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include, but are not limited to: general and international economic, political and other risks, including currency and stock market fluctuations and the uncertain economic environment in Europe as a result of the recent vote by the United Kingdom to exit from the European Union; our customer or therapeutic area concentration; and the other risk factors set forth from time to time in our Form 10-K for the year ended December 31, 2015, Form 10-Q for the quarter ended June 30, 2016 and other SEC filings, copies of which are available free of charge on our website at incresearch.com. INC Research assumes no obligation and does not intend to update these forward-looking statements, except as required by law.